Why it was recalled
Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Product description
Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Rochelle Park, NJ 07662, NDC 29300-128-10
Lot numbers, UPCs & expiration codes
Lot #: GHYL15028, Exp April 2018
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1352-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 30, 2015
- FDA report date
- Sep 2, 2015
- Quantity
- 4776 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Unichem Pharmaceuticals Usa Inc
Original FDA data
Every field from FDA enforcement report D-1352-2015, exactly as published.
Show all FDA fields
- City
- Rochelle Park
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71860
- Address
- 201 W Passaic St Ste 403
- Code information
- Lot #: GHYL15028, Exp April 2018
- Postal code
- 07662-3128
- Report date
- Sep 2, 2015
- Product type
- Drugs
- Recall number
- D-1352-2015
- Classification
- Class II
- Recalling firm
- Unichem Pharmaceuticals Usa Inc
- Product quantity
- 4776 bottles
- Termination date
- Oct 19, 2018
- Reason for recall
- Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Rochelle Park, NJ 07662, NDC 29300-128-10
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 30, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 25, 2015